Stryker Senior Quality Engineer - Distribution Center in Plainfield, Indiana
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Who we want
Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
User-focused creators. Engineers who design with the user in mind, developing processes and practices that help maintain compliance and support growth
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do
As a Senior Quality Engineer – Central Distribution Center you will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement processes. You will support quality issues and potential nonconforming material disposition processes impacting daily operations. You will manage the US CDC QMS parts regarding Value Added Services, advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.
You will work closely with CDC operations, 3rd party leadership, global CDC team and divisional business functions to ensure quality performance of services and processes.
YOU will support identified internal and support supplier driven non-conformances and manage the timely closure of NC's within.
You will own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.
You will engage in the development and improvement of the internal Labeling and Kitting (Value-Added Services) processes for existing product or services
You will maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions related to continuous improvement and change management.
You will support execution and where applicable analysis of CDC related complaints and product field actions.
You will be an advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
You should have a developed understanding of risk management practices and concepts and applies knowledge to CDC and supplier operations (ISO 14971).
You will engage, perform and interface in internal and external audits providing subject matter expertise.
You will support manufacturing transfers to the CDC, executing appropriate quality activities.
You will need to draw on significant knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
You will need to be flexible and adaptable to demonstrate ability to multi-task and communicate effectively through project management and influence partners without authority.
What you need
Bachelor’s degree in science, engineering or related discipline required
2 + years’ experience minimum in a regulated industry, Medical Device or Pharmaceuticals manufacturing environment highly preferred.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program. (https://careers.stryker.com/referrals/)
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